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Sponsor: Insel Gruppe AG, University Hospital Bern
Conditions: Liver Cirrhosis
Interventions: Rivaroxaban 10 mg Oral Tablet, Apixaban 2.5 mg Oral Tablet
Countries: Switzerland
The aim of this study is to investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban and apixaban in patients with compensated liver cirrhosis (Child-Pugh class A and B). The enrolled participants receive a prophylactic single oral dose of either rivaroxaban (10 mg) or apixaban (2.5 mg) at around 8 a.m. on the day of the trial. Blood samples are taken 0.5 hours pre-dose and 1, 2, 3, 4, 6, 8, 12 hours post-dose. A follow-up telephone call is performed 5 days after the study intervention to collect safety data.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Age 18 years or older * Patient with previously diagnosed liver cirrhosis (Child-Pugh score grade A and B). * Written informed consent Exclusion Criteria: * Positive pregnancy test (only for women in childbearing age with intact uterus), pregnancy or nursing women * Intake of prophylactic or therapeutic oral anticoagulant (phenprocoumon, acenocoumarol, dabigatran etc.) 2 weeks prior to inclusion in the study * Application of parenteral anticoagulant, e.g. unfractionated heparin, low molecular weight heparins, heparin derivatives (fondaparinux etc.) 1 week prior to inclusion in the study * Pharmacologic platelet inhibition within 2 weeks prior to inclusion in the study * Known coagulation disorders (e.g. von Willebrand's disease, hemophilia) * Active, clinically significant bleeding * Congenital or acquired bleeding disorder * High risk of bleeding (e.g. active ulcerative gastrointestinal disease) * Uncontrolled severe hypertension * Vascular retinopathy * Acute infection * Acute bacterial endocarditis * Severe anemia (haemoglobin ≤100 g/L) * Hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption * Severe liver dysfunction (Child-Pugh Score grade C) * Hepatic encephalopathy ≥ grade 3 * Severe renal impairment with a creatinine clearance (GFR) of \<30 ml/min * Known intolerance to the study medications rivaroxaban and/or apixaban * Concomitant treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, lopinavir, ritonavir, indinavir). * Concomitant treatment with a P-glycoprotein inhibitor and a weak or moderate CYP3A4 inhibitor (e.g., erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine). * Concomitant treatment with a P-glycoprotein inducer and a strong CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampicin). * Wash-out period of less than two weeks prior to the application of study drug in case of prior treatment with a strong CYP3A4 inhibitor or a P-glycoprotein inhibitor and weak or moderate CYP3A4 inhibitor or with a P-glycoprotein inducer or strong CYP3A4 inducer.
- Bern, Switzerland